Nimbus Therapeutics is ramping up its pursuit of Bristol Myers Squibb’s plaque psoriasis drug Sotyktu, committing to moving a rival TYK2 inhibitor into phase 3 after hitting the primary endpoint in a midstage study.
Interest in TYK2 heightened as safety issues with JAK inhibitors, including more selective second-generation molecules, came to light and led to black box warnings. TYK2 is a JAK in all but name. But by targeting its allosteric site, Bristol Myers, Nimbus and Ventyx Biosciences look to have improved selectivity and, by extension, safety. Bristol Myers’ Sotyktu came to market without a black box warning.
While NDI-034858 is trailing far behind the now-approved Sotyktu, Nimbus has pitched the molecule as a potential best-in-class TYK2 inhibitor capable of carving out a chunk of the market. Now, the biotech has data it claims support its confidence in the molecule.
Nimbus is yet to share the numbers from the phase 2b study, but, by its reckoning, the “results support best-in-class potential of NDI-034858 among allosteric TYK2 inhibitors.” Significantly more people taking NDI-034858 had a 75% or greater improvement in skin lesions than in the placebo arm, causing the trial to hit its primary endpoint. The study tested four doses, but Nimbus is yet to delineate its findings.
Among the other crumbs of information shared by Nimbus was the news that the study of 259 people with moderate to severe plaque psoriasis met “additional endpoints” and that safety “was consistent with other leading allosteric TYK2 inhibitors.” Nimbus saw grade 3 or worse cases of triglyceride abnormalities, elevation of a tissue damage biomarker and low white blood cells in its phase 1b study.
The biotech is holding off on sharing the full phase 2b data until an upcoming medical conference but is already making plans based on the results. A phase 3 clinical trial is set to start next year. Nimbus is also studying NDI-034858 in psoriatic arthritis patients in another phase 2b trial and plans to expand its R&D program into other autoimmune indications including inflammatory bowel disease and lupus.
Nimbus laid the financial foundations for the move into phase 3 and expansion of its slate of NDI-034858 trials in September when it pulled in $125 million from backers including Pfizer in a private round that freed it to stay out of the bear pit of public markets for now.